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The device is a motor-driven, and indoor transportation vehicle with the intended use to provide mobility to a disabled or an elderly person limited to a seated position.

The Model XW-LY001 Electric wheelchair is powered by Li-ion battery, driven by DC motor. Users control direction and adjust speed by controller. It is suitable to be used in low speed, good road condition and small slope. The electric wheelchair consists of two foldable armrests, a backrest, a seat cushion, a foldable frame, two rear driving wheels with hub motor/electromagnetic brake assemblies, two pivoting casters, a Li-ion batteries, an off-board battery charger, a control panel, and an electric motor controller. The subject device has 8 inch front wheel and 12.5 inch rear wheel. The motor of electric wheelchair is DC24V 200W; the battery is 25.2V 10.4Ah Li-ion battery; the charger is DC 24V, 2A. Max. loading can not be over than 125Kgs, and its maximum speed is 6km/h. The braking time is about 2-3s,and the braking distance is ≤1.5m

The provided FDA 510(k) summary (K200423) for the Electric Wheelchair (XW-LY001) details non-clinical tests to demonstrate substantial equivalence to a predicate device (K170787). This document does not describe a study involving an AI device or a comparative effectiveness study with human readers. Therefore, several aspects of your request related to AI performance, human reader improvement, and ground truth establishment for AI models cannot be addressed from the given text.

Based on the provided information, here's a breakdown of the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are its compliance with various ISO and IEC standards for wheelchairs and the demonstration of substantial equivalence to a predicate device. The reported device performance is presented as compliance with these standards and a comparison of its characteristics to the predicate device.

The "study that proves the device meets the acceptance criteria" is described as "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." (page 5, "7.0 _Non-Clinical Test Conclusion"). These tests demonstrated compliance with the listed ISO and IEC standards.

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of data or AI model evaluation. The tests conducted were non-clinical performance and safety tests of the physical wheelchair device. The provenance of the data is not applicable in this context as it refers to physical testing results against engineering standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not an AI device or a diagnostic device where expert ground truth would be established for image or data interpretation. The "ground truth" here is the pass/fail criteria defined by the ISO and IEC standards.

4. Adjudication method for the test set

Not applicable, as there is no human adjudication of a test set in the context of this device's non-clinical safety and performance testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted diagnostic or interpretation device. No MRMC study was performed or is relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used

The "ground truth" for the device's performance is adherence to the specifications and performance metrics outlined in the various international standards (ISO and IEC) for wheelchairs and medical devices. These standards define the acceptable range or criteria for parameters like static stability, dynamic stability, braking effectiveness, energy consumption, dimensions, maximum speed, strength, climatic performance, obstacle climbing, power/control systems, electromagnetic compatibility, battery safety, and biocompatibility.

8. The sample size for the training set

Not applicable, as this is not an AI device that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as this is not an AI device that requires a training set or ground truth establishment for AI models.

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The device is a motor-driven, and indoor transportation vehicle with the intended use to provide mobility to a disabled or an elderly person limited to a seated position.

The proposed device, Electric wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick and adjusting speed. The electric wheelchair consists of two foldable armrests, a backrest, a seat cushion, a foldable frame, two rear driving wheels with hub motor/electromagnetic brake assemblies, two pivoting casters, a Li-ion batteries, an off-board battery charger, a control panel, and an electric motor controller. The electric wheelchair is intended to provide mobility to a person with a disability or an older adult limited to a sitting position.

The provided text is a 510(k) Premarket Notification for an Electric Wheelchair. It focuses on demonstrating substantial equivalence to a predicate device rather than describing acceptance criteria and a study proving a device meets those criteria, particularly in the context of an AI/medical imaging device. As such, it does not contain the specific information required to answer the prompt comprehensively for an AI-based device.

However, I can extract information related to how this specific device (an electric wheelchair) demonstrates its safety and effectiveness, which serves a similar purpose to "acceptance criteria" and "proving it meets them." The "study" here is non-clinical testing against established engineering standards.

Here's an attempt to answer the prompt based on the provided document, acknowledging that it's for a physical device, not an AI:

Acceptance Criteria and Study for the Electric Wheelchair (Models: JRWD6010 and JRWD6012)

The "acceptance criteria" for this electric wheelchair are primarily defined by adherence to a comprehensive set of ISO standards specific to wheelchairs and related electrical and material safety. The "study" demonstrating the device meets these criteria is a series of non-clinical tests conducted against these standards.

1. Table of Acceptance Criteria and Reported Device Performance

The document defines acceptance relative to a predicate device and extensive non-clinical testing against ISO standards. The table below summarizes key performance characteristics and their reported values, demonstrating compliance or acceptable differences compared to the predicate device and relevant standards. The "remark" column often serves as the "acceptance" or justification for differences.

Note: The document states "Not publicly available" for some predicate device values, and "Same" for others. Where specific numbers for the predicate are missing, the comparison is qualitative or based on standard compliance.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify a "sample size" in terms of number of devices tested. It refers to extensive non-clinical tests conducted on the proposed device models (JRWD6010 and JRWD6012). For physical device testing against engineering standards, typically a representative number of units (often a small number, e.g., 1-3) are tested to demonstrate compliance of the design.
• Data Provenance: The testing was non-clinical (laboratory/benchtop) and conducted by the manufacturer, Jerry Medical Instrument (Shanghai) Co., Ltd. The document does not explicitly state the country of origin of the test data (beyond the manufacturer's location) or whether it was retrospective or prospective, but it implies a prospective testing approach conducted specifically for this submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

This information is not applicable as this document describes non-clinical testing of a physical medical device (electric wheelchair), not an AI/imaging device. The "ground truth" for a physical device is established through calibrated measurement instruments and adherence to internationally recognized engineering standards (ISO). There's no mention of experts in the context of "ground truth" for the performance metrics.

4. Adjudication Method for the Test Set

This is not applicable as there is no mention of human readers or subjective assessments requiring adjudication. The tests described are objective, quantitative measurements against predefined criteria in engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

This is not applicable. No MRMC study was performed or is relevant for this type of device. The document explicitly states "No clinical study implemented for the electric wheelchair."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable. This document describes a physical electric wheelchair, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the electric wheelchair's performance is based on:

• Adherence to international engineering standards (e.g., ISO 7176 series for wheelchairs, IEC 60601-1-2 for EMC, ISO 10993 for biocompatibility). These standards define test methods and acceptable performance limits.
• Comparison to a legally marketed predicate device, demonstrating that any differences in specifications do not raise new questions of safety or effectiveness.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is a physical device, not an AI/machine learning model.

9. How the Ground Truth for the Training Set was Established

This is not applicable as there is no training set for this physical device.

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